BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1770608 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09312
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    August 13, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    UPON EVALUATION BY THE MANUFACTURER, IT WAS CONFIRMED THE LANCET DOES NOT RETRACT INTO THE MULTICLIX DEVICE AFTER FIRING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE SUSPECT DEVICE AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR026

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HUMALOG - SLIDING SCALE| LANTUS, DOSE UNK